FDA 483 OBSERVATION · #714 OF 1,932 MOST-CITED
Procedures and release criteria
FDA cited this observation 29 times across 28 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
Procedures including release criteria for activities relating to the receipt and distribution of HCT/Ps were not maintained, implemented, reviewed and revised.
Procedures including release criteria for activities relating to the distribution of HCT/Ps were not established and maintained.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not established and documented.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not documented, implemented and followed.
Procedures including release criteria for activities relating to the receipt, shipment and distribution of HCT/Ps were not established.
Procedures including release criteria for activities relating to the receipt of HCT/Ps were not followed.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →